Film coating: effect of titanium dioxide concentration and film thickness on the photostability of nifedipine

Béchard, Simon; Quraishi, Omar; Kwong, Elizabeth

doi:10.1016/0378-5173(92)90236-u

Cited by 67 publications

(12 citation statements)

References 10 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Drug products, which are sensitive to this light range, such as, for example, nifedipine tablets,2 are not photostabilized by titanium dioxide. Neither the incorporation of the pigment into the tablet core,11 nor coating with titanium dioxide films,12 nor packaging into white opaque blisters (colored with titanium dioxide)13 considerably improved the light sensitivity of nifedipine tablets. General applicability must therefore be denied.…”

Section: Discussionmentioning

confidence: 99%

How to photostabilize molsidomine tablets**This article is dedicated to the memory of Prof. Dr. K. Thoma.

Thoma

2004

Journal of Pharmaceutical Sciences

View full text Add to dashboard Cite

Section: Discussionmentioning

confidence: 99%

How to photostabilize molsidomine tablets**This article is dedicated to the memory of Prof. Dr. K. Thoma.

Thoma

2004

Journal of Pharmaceutical Sciences

View full text Add to dashboard Cite

“…The radical scavengers used were as follows: NaN 3 , a singlet oxygen scavenger; BHT, a hydroxyl radical scavenger; and VC, a superoxide scavenger. 23 The addition of all radical scavengers led to a protective effect against the photodegradation of FMT/RF; in particular, VC showed ca. 86% attenuation of photodegradation (Fig.…”

Section: Photostability Of Fmt/rfmentioning

confidence: 98%

Photochemical Mechanism of Riboflavin-Induced Degradation of Famotidine and a Suggested Pharmaceutical Strategy for Improving Photostability

Uchida

Onoue

Ohtake

et al. 2016

Journal of Pharmaceutical Sciences

View full text Add to dashboard Cite

The present study aimed to clarify the mechanism of photodegradation of famotidine with riboflavin (FMT/RF), and to develop a photochemically stabilized formulation of FMT/RF. Photochemical properties of RF were characterized by UV-VIS spectral analysis, reactive oxygen species (ROS) assay, and photostability testing. Pharmacokinetic study was conducted in rats after intravenous administration of FMT (1 mg/kg) formulation containing RF (0.01 mg/kg). The UV-VIS spectral pattern of RF partly overlapped with the sunlight spectrum, and ROS generation from photoirradiated RF was remarkable; thus, RF had high photoreactive potential. In the photostability testing, after irradiation (250 W/m(2)), degradation rate for FMT in FMT/RF was ca. 11-fold higher than that in FMT alone. The addition of radical scavengers to FMT/RF led to attenuated photodegradation of FMT/RF; in particular, the addition of L-ascorbic acid (vitamin C; VC) to FMT/RF showed ca. 86% inhibition of the photodegradation of FMT/RF. The pharmacokinetic study on FMT indicated that the addition of VC (1 mg/kg) to FMT/RF had no significant impact on the pharmacokinetic behavior of FMT. These findings suggest that ROS-mediated photochemical reaction would be involved in the photodegradation pathway of FMT/RF, and the complementary use of VC might be an attractive approach to improve the photostability of FMT/RF.

show abstract

“…The opaqueness can be obtained by adding a pharmaceutically acceptable dye the absorption spectrum of which is the same as that of the drug principle or by adding a reflecting pigment such as titanium dioxide. [67]…”

Section: Introductionmentioning

confidence: 99%

Effect assessment of "film coating and packaging" on the photo-stability of highly photo-labile antihypertensive products

Mukharya

Patel

Chaudhary

2013

Int J Pharma Investig

View full text Add to dashboard Cite

Introduction:Lacidipine (LCDP) is chemically a “1, 4-dihydropyridine derivative” Ca+2 channel blocker used as an antihypertensive. Type and extent of packaging have a strong influence on the photo-stability of the 1,4-dihydropyridine derivatives. In standard, light protection of drug substance/drug product can be obtained either by use of an opaque additive in the formulation that competitively absorbs or reflects light reaching the sample and/or by blocking the access of light to the drug through external protection by packaging.Materials and Methods:External protection by covering tablets with an opaque film coating involving a light-reflecting inorganic pigment such as titanium dioxide and/or by using an opaque impermeable packaging material was an appropriate suitable option for establishing photo-stability. Thus, the main objective of the present study was to optimize the % level of film coating in LCDP core tablets, and selection of a final packaging material and its respective extent, that is, primary, secondary and/or tertiary packaging, for LCDP tablets.Results and Conclusion:The main objective (% level of film coating) was optimized by directly exposing core tablets, 1% w/w, 2% w/w and 3% w/w film-coated tablets, to a light source as per Option-2 of ICH Q1B and its comparative analysis at the end of light exposure testing. The other objective (extent of drug product packaging) was established successfully by assessing whether or not an acceptable change has occurred at the end of the light exposure testing of the LCDP film-coated tablets in a direct exposure study or a primary immediate pack and/or secondary marketing pack.

show abstract

Film coating: effect of titanium dioxide concentration and film thickness on the photostability of nifedipine

Cited by 67 publications

References 10 publications

How to photostabilize molsidomine tablets**This article is dedicated to the memory of Prof. Dr. K. Thoma.

How to photostabilize molsidomine tablets**This article is dedicated to the memory of Prof. Dr. K. Thoma.

Photochemical Mechanism of Riboflavin-Induced Degradation of Famotidine and a Suggested Pharmaceutical Strategy for Improving Photostability

Effect assessment of "film coating and packaging" on the photo-stability of highly photo-labile antihypertensive products

Contact Info

Product

Resources

About